In asthma, clinical response is characterised by disease improvement with treatment, whereas clinical remission is characterised by long-term disease stabilisation with or without ongoing treatment. The proportions of patients receiving tezepelumab who responded to treatment and who achieved on-treatment clinical remission were assessed in the NAVIGATOR (ClinicalTrials.gov identifier NCT03347279) and DESTINATION (ClinicalTrials.gov identifier NCT03706079) studies of severe, uncontrolled asthma.

NAVIGATOR and DESTINATION were phase 3, randomised, double-blind, placebo-controlled studies; DESTINATION was an extension of NAVIGATOR. Complete clinical response was defined as achieving all of the following: ≥50% reduction in exacerbations versus the previous year, improvements in pre-bronchodilator (BD) forced expiratory volume in 1 s (FEV₁) of ≥100 mL or ≥5%, improvements in Asthma Control Questionnaire (ACQ)-6 score of ≥0.5 and physician's assessment of asthma improvement. On-treatment clinical remission was defined as an ACQ-6 total score ≤1.5, stable lung function (pre-BD FEV₁ >95% of baseline) and no exacerbations or use of oral corticosteroids during the time periods assessed.

Higher proportions of tezepelumab than placebo recipients achieved complete clinical response over weeks 0–52 (46% versus 24%; OR 2.83, 95% CI 2.10–3.82) and on-treatment clinical remission over weeks 0–52 (28.5% versus 21.9%; OR 1.44, 95% CI 0.95–2.19) and weeks >52–104 (33.5% versus 26.7%; OR 1.44, 95% CI 0.97–2.14). Tezepelumab recipients who achieved on-treatment clinical remission versus complete clinical response at week 52 had better preserved lung function and lower inflammatory biomarker levels at baseline, and fewer exacerbations in the 12 months before the study.

Among patients with severe, uncontrolled asthma, tezepelumab treatment was associated with an increased likelihood of achieving complete clinical response and on-treatment clinical remission compared with placebo. Both are clinically important outcomes, but may be driven by different patient characteristics.

在哮喘中，临床反应的特征是治疗后疾病改善，而临床缓解的特征是疾病长期稳定，有或没有持续治疗。在严重、未控制的哮喘的 NAVIGATOR （ClinicalTrials.gov 标识符 NCT03347279） 和 DESTINATION （ClinicalTrials.gov 标识符 NCT03706079） 研究中评估了接受 tezepelumab 治疗反应并达到治疗中临床缓解的患者比例。

NAVIGATOR 和 DESTINATION 是 3 期、随机、双盲、安慰剂对照研究;DESTINATION 是 NAVIGATOR 的扩展。完全临床反应定义为达到以下所有水平：与上一年相比，病情恶化减少 ≥50%，支气管扩张剂前 （BD） 1 秒用力呼气容积 （FEV₁） 改善 ≥100 mL 或 ≥5%，哮喘控制问卷 （ACQ）-6 评分改善 ≥0.5 和医生对哮喘改善的评估。治疗中临床缓解定义为 ACQ-6 总分 ≤1.5，肺功能稳定（BD 前 FEV₁ 基线的 >95%）并且在评估的时间段内没有恶化或使用口服皮质类固醇。

与安慰剂接受者相比，tezepelumab 比例更高，在第 0-52 周内达到完全临床反应 （46% 对 24%;OR 2.83,95% CI 2.10-3.82）和第 0-52 周的治疗临床缓解 （28.5% 对 21.9%;OR 1.44,95% CI 0.95-2.19）和周 >52-104 （33.5% 对 26.7%;OR 1.44,95% CI 0.97-2.14）。与完全临床反应相比，在第 52 周达到治疗中临床缓解的 Tezepelumab 受者在基线时肺功能保存得更好，炎症生物标志物水平更低，在研究前 12 个月内恶化更少。

在严重、未控制的哮喘患者中，与安慰剂相比，tezepelumab 治疗与实现完全临床反应和治疗中临床缓解的可能性增加相关。两者都是临床上重要的结局，但可能由不同的患者特征驱动。